[18F]PSMA-11 PET/CT for Prostate Cancer - Phase 3 Clinical Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- Evaluation of the non-inferiority of [18F]PSMA-11 compared to [68Ga]PSMA-11 with respect to the number of positive PET scans. Hereby, a positive PET scan is defined as a scan showing at least one suspected lesion.
研究概览
简要总结
Prostate cancer (PCa) is the most frequently occurring male cancer in Belgium. After treatment with surgery and/or radiotherapy, almost half of the patients suffer from a tumor recurrence, often diagnosed by an increase in serum tumor marker Prostate Specific Antigen (PSA) within the first few years after primary treatment. However, for salvage therapy to be successful, precise localization of metastases is necessary to determine the most appropriate treatment. In so-called oligo-metastatic disease targeted therapy may still be curative and prevent the disease from spreading to distant locations. Therefore it is of paramount importance to have an accurate tool of medical imaging to localize all possible locations to be treated.
Recently, prostate specific membrane antigen (PSMA) has gained interest for PCa-specific imaging. Due to overexpression of PSMA in both primary and metastatic PCa, radiotracers targeting this protein have shown an increased selectivity and sensitivity compared to conventional imaging. The main objective of this phase 3 trial is to determine the position of [18F]PSMA-11 PET/CT within the field of available radiotracers for diagnosis of prostate cancer. For this, the diagnostic performances of [18F]PSMA-11 will be compared to those of the current state-of-the-art radiotracer [68Ga]PSMA-11.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The assigned scan order will be blind to the recruiting physicians and the nuclear medicine physicians interpreting the images.
Next to the clinical trial coordinators, also the staff members responsible for the preparation of the individual [18F]PSMA-11 and [68Ga]PSMA-11 dose and the IV injection of this dose are aware of the scan order which means that they are NOT blinded. However, these staff members do not carry out any further study specific handlings.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with prostate cancer, either in the setting of diagnosis of biochemical recurrence after previous treatment, or at primary diagnosis and staging.
排除标准
- •Age < 18 years
- •Physically or mentally unfit to perform the sequential procedures
- •Refusal of patient to be informed about accidental findings on scans
- •History of anaphylactic shock after administration of Visipaque CT contrast
- •Serum creatinine concentration > 2.0 mg/dl and/or estimated glomerular filtration rate < 60 ml/min.
结局指标
主要结局
Evaluation of the non-inferiority of [18F]PSMA-11 compared to [68Ga]PSMA-11 with respect to the number of positive PET scans. Hereby, a positive PET scan is defined as a scan showing at least one suspected lesion.
时间窗: 0 to 100 minutes post injection for both [18F]PSMA-11 and [68Ga]PSMA-11
The non-inferiority of \[18F\]PSMA-11 will be investigated based on a Tango's score two-sided 95% confidence interval (CI) for a difference of proportions of positive scans of \[18F\]PSMA-11 compared to \[68Ga\]PSMA-11 with matched pairs. Non-inferiority will be concluded if the lower limit of this CI is larger than 0.10 (non-inferiority limit).
次要结局
- Evaluation of the superiority of [18F]PSMA-11 compared to [68Ga]PSMA-11 with respect to the total number of suspected prostate cancer lesions in corresponding ([68Ga]PSMA-11 vs [18F]PSMA-11) scans.(0 to 100 minutes post injection for both [18F]PSMA-11 and [68Ga]PSMA-11)
- Evaluation of the diagnostic specificity of [18F]PSMA-11 compared to [68Ga]PSMA-11(0 to 180 days post [18F]PSMA-11 and [68Ga]PSMA-11 administration)
- Assessment of the interobserver variability with regard to the evaluation of the [18F]PSMA-11 and [68Ga]PSMA-11 PET scans(0 to 100 minutes post injection for both [18F]PSMA-11 and [68Ga]PSMA-11)
- Evaluation of the safety of [18F]PSMA-11 administration: CTCAE 4.0 criteria(0 to 24 h post [18F]PSMA-11 and [68Ga]PSMA-11 administration)
- Evaluation of the superiority of [18F]PSMA-11 compared to [68Ga]PSMA-11 with respect to the number of positive PET scans. Hereby, a positive PET scan is defined as a scan showing at least one suspected lesion.(0 to 100 minutes post injection for both [18F]PSMA-11 and [68Ga]PSMA-11)
- Evaluation of the superiority of [18F]PSMA-11 compared to [68Ga]PSMA-11 with respect to the scoring of corresponding ([68Ga]PSMA-11 vs [18F]PSMA-11) suspected lesions.(0 to 100 minutes post injection for both [18F]PSMA-11 and [68Ga]PSMA-11)
- Descriptive evaluation of [18F]PSMA-11 compared to [68Ga]PSMA(0 to 100 minutes post injection for both [18F]PSMA-11 and [68Ga]PSMA-11)